Biocompatibility of Cellulose Acetate Sheets produced by Mazzucchelli 1849.
According to Regulation (EU) 2017/745 on medical devices, frames with ophthalmic lenses fall under the category of medical devices class I.
In order to evaluate the biocompatibility of these medical devices a test protocol must be followed, as defined by the ISO 10993 standard which states its procedure.
Mazzucchelli, which has always been attentive to comply with all the regulatory and safety requirements of its materials, has decided to carry out, with the support of ANFAO, an assessment of its products in the supply conditions, in such a way as to be able to support, with these evaluations, the possible certification activity of its customers.
Mazzucchelli has been producing, with proprietary formulas, Cellulose Acetate sheets since 1936 and has organized internally a structured and thorough method for the management and the evaluation of the substances and the collection of reports from the market. Mazzucchelli has also carried out the tests required by the ISO 10993 standard on the two main formulations (Standard Plasticized Material DEP and M49) with positive results and has submitted the entire documentation to medical consultants working in hospitals who, in turn, have provided favorable opinions on biocompatibility.
Mazzucchelli therefore guarantees that its products, on the basis of the tradition of use, the extensive literature collected and the tests carried out, can be considered non-irritants and non-skin sensitizing. Nevertheless, it cannot be ruled out that individual cases of irritation or skin sensitization due to one or more constituents used may occur.
The results of the work done by Mazzucchelli are exclusively valid for Cellulose Acetate sheets produced by all the companies belonging to the Group.